Magnetic resonance imaging-guided focused ultrasound thalamotomy launch with remote telemedicine international proctorship.

Background: COVID-19 limitations have hindered the implementation of new technologies by preventing proctors from coming to the site. We share our first experience of magnetic resonance imaging (MRI)-guided focused ultrasound (MRgFUS) treatment with an international remote online proctorship, and develop and evaluate the methodology of remote MRgFUS proctorship. Methods: This single-center, nonrandomized controlled prospective study included 94 patients: 27 with essential tremor (ET) and 67 with tremor-dominant Parkinson's disease (PD). The coming of proctors was impossible, so we arranged for the remote participation of proctors from the United Kingdom, Spain, and Israel. A total of 38 patients (40.4%) received telemedicine-proctored treatment (proctor group) and 56 received their treatment independently (solo group). We used the Clinical Rating Scale for Tremor (CRST) for ET patients and the Unified Parkinson's Disease Rating Scale (UPDRS) Part III for PD patients. Results: In patients with ET, success rates were 81.8% (proctor group) and 100% (solo group) (p = 0.22). CRST reduction on the treated side was 71.43% [65.83%; 80.56%] (proctor group) versus 60.87% [53.99; 79.58] (solo group) (p = 0.19). None of the patients showed worsening of tremors within 1 year. In patients with PD, the success rates were 92.6% (proctor group) and 100% (solo group) (p = 0.08). The UPDRS Part III improvement was 30.1% (proctor group) versus 39.9% (solo group) (p = 0.003). The 1-year recurrence rate was 40% (proctor group) and 17.5% (solo group) (p = 0.04). No complications were observed at 6 months. Conclusions: We developed a feasible and safe methodology for telemedicine remote online-proctored MRgFUS treatment. No significant difference was observed between the solo and developed remote proctor protocols in terms of complication rate, effect, and long-term results; however, UPDRS Part III improvement was better in the PD solo group. This study demonstrated that the MRgFUS international proctorship can be performed successfully remotely.

Safety, Efficacy and Long-Term Outcomes of Patients Treated with the Occlutech Paravalvular Leak Device for Significant Paravalvular Regurgitation.

Between December 2014 and March 2021, 144 patients with aortic (Ao) or mitral (Mi) paravalvular leaks (PVLs) were enrolled at 21 sites in 10 countries. Safety data were available for 137 patients, who were included in the safety analysis fraction (SAF), 93 patients with Mi PVLs and 44 patients with Ao PVLs. The full analysis set (FAS) comprised 112 patients with available stratum (aortic/mitral leak) as well as baseline (BL), 180-day or later assessments (2 years). Procedural success (implantation of the device with a proper closure of the PVL, defined as reduction in paravalvular regurgitation of ≥one grade as assessed by echocardiography post implantation) was achieved in 91.3% of FAS patients with Mi PVLs and in 90.0% of those with Ao PVLs. The proportion of patients suffering from significant or severe heart failure (HF), classified as New York Heart Association (NYHA) class III/IV, decreased from 80% at baseline to 14.1% at 2-year follow-up (FAS). The proportion of FAS patients needing hemolysis-related blood transfusion decreased from 35.5% to 3.8% and from 8.1% to 0% in Mi patients and Ao patients, respectively. In total, 35 serious adverse events (SAEs) were reported in 27 patients (19.7%) of the SAF population. The SAEs considered possibly or probably related to the device included device embolization (three patients), residual leak (two patients) and vascular complication (one patient). During follow-up, 12/137 (8.8%) patients died, but none of the deaths was considered to be device-related. Patients implanted with the Occlutech Paravalvular Leak Device (PLD) showed long-lasting improvements in clinical parameters, including NYHA class and a reduced dependency on hemolysis-related blood transfusions.

EchoNavigator® technology facilitates transapical mitral paravalvular leak closure: a case report.

BACKGROUND: Catheter-based closure has emerged as a less invasive alternative to surgery in high-risk patients with paravalvular leak (PVL) and clinically significant regurgitation with feasibility and efficacy demonstrated in multiple studies. CASE SUMMARY: A 72-year-old female with a past history of long-standing rheumatic heart disease underwent mechanical mitral valve replacement in 2008. Ten years later, redo surgery was performed due to a worsening mitral PVL and the leakage was closed by direct pledget-supported sutures, preserving the mechanical valve. She was recently admitted again for haemolytic anaemia and congestive heart failure (New York Heart Association Classes III-IV) due to a recurrent mitral PVL. We report our initial clinical experience using a novel software solution (EchoNavigator®-system) for intuitive guidance during a catheter-based transapical mitral PVL closure. DISCUSSION: Transapical mitral PVL closure with a specifically designed device demonstrated in our case to be a better option than redo surgery. Recently introduced fusion imaging modalities enhanced visualization of soft tissue anatomy and device location improving enormously the results of this challenging intervention.

Case Report: Coil Occlusion of Two Congenital Coronary Cameral Fistulas Connecting Right and Left Circumflex Arteries to the Right Ventricle: An Innovative Stent-Assisted Technique.

BACKGROUND: Coronary cameral fistulas (CCFs) are rare congenital malformations consisting of abnormal vascular connections between coronary arteries and cardiac chambers, often incidentally found during cardiac catheterizations. CASE SUMMARY: A 66-year-old female asymptomatic patient, without cardiovascular risk factors and a history of varicose veins lower extremities and coronavirus disease 2019 (COVID-19) pneumonia in December 2020, was diagnosed by coronary angiography with two large coronary cameral fistulas connecting the distal right coronary artery (RCA) and the distal left circumflex artery (LCx) to the right ventricle (RV). Additional imaging modalities such as two-dimensional transthoracic/transesophageal echocardiography and three-dimensional multidetector CT angiography were required to confirm the fistula's pathway (location, number, and size), which was difficult to delineate using selective coronary angiography alone. After heart team discussion, with the aim to reduce the risk of embolization, an innovative stent-assisted coil occlusion antegrade technique was used with optimal immediate results. DISCUSSION: Even though our otherwise asymptomatic patient was not the best suitable candidate for an interventional procedure (large vessels, multiple fistulas without distal narrowing, distal portion of the fistula not accessible with the closure device), the innovative stent-assisted fistula coil occlusion technique to stabilize the first coil and deploy safely the additional ones resulted to be key for successful and complete obliteration of the abnormal congenital vascular connections.

«A case of a pharmacoresistant tachyarrhythmia associated with Arnold-Chiari malformation¼.

Introduction: Arnold-Chiari malformation is a group of congenital malformations of the hindbrain. Common symptoms include cephalgia, vestibular, cerebral and cochlear disorders We present a case of pharmacoresistant tachyarrhythmia associated with Arnold-Chiari malformation.Case Description: A 49-year-old female patient had an Arnold-Chiari malformation (ACM), syringomyelia, a retrocerebellar cyst and a 6 year history of tachyarrhythmia. Heart rhythm normalized after Chiari decompression.Conclusion: ACM can lead to heart rhythm disorders.

Artificial intelligence: Neural network model as the multidisciplinary team member in clinical decision support to avoid medical mistakes.

OBJECTIVE: The continuous uninterrupted feedback system is the essential part of any well-organized system. We propose aLYNX concept that is a possibility to use an artificial intelligence algorithm or a neural network model in decision-making system so as to avoid possible mistakes and to remind the doctors to review tactics once more in selected cases. METHOD: aLYNX system includes: registry with significant factors, decisions and results; machine learning process based on this registry data; the use of the machine learning results as the adviser. We show a possibility to build a computer adviser with a neural network model for making a choice between coronary aortic bypass surgery (CABG) and percutaneous coronary intervention (PCI) in order to achieve a higher 5-year survival rate in patients with angina based on the experience of 5107 patients. RESULTS: The neural network was trained by 4679 patients who achieved 5-year survival. Among them, 2390 patients underwent PCI and 2289 CABG. After training, the correlation coefficient (r) of the network was 0.74 for training, 0.67 for validation, 0.71 for test and 0.73 for total. Simulation of the neural network function has been performed after training in the two groups of patients with known 5-year outcome. The disagreement rate was significantly higher in the dead patient group than that in the survivor group between neural network model and heart team [16.8% (787/4679) vs. 20.3% (87/428), P = 0.065)]. CONCLUSION: The study shows the possibility to build a computer adviser with a neural network model for making a choice between CABG and PCI in order to achieve a higher 5-year survival rate in patients with angina.